MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Despite the report of a blood clot in the suction tubing, jada successfully treated this patient's post partum hemorrhage.

Event Description

Patient is a (b)(6)-year-old gravida 4 with 3 previous live births (1 vaginal delivery and 2 cesarean).She presented to labor and delivery for a scheduled repeat cesarean at 39 weeks gestation.A (b)(6) infant was delivered and pitocin was started at the delivery of placenta for active management of the third stage of labor.Uterine atony, including lower uterine segment bleeding, was identified and treated with misoprostol and methergine im.Approximately 2.5 hours after delivery of the placenta and 1160 qbl of blood loss, jada was inserted.Jada was able to control the bleeding successfully.Unknown how much blood was noted in the suction cannister during treatment.At the time of removal, the rn noticed that jada was not suctioning, and a clot was expressed from the vagina.The position of jada was verified as correct, and wall suction was working.There was a clot that was unable to be flushed in the suction tubing connecting jada to the regulator.Jada was removed without further incident and bleeding was controlled with no escalation of care.Admission date: (b)(6) 2020.Discharge date: (b)(6) 2020.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: richard ferrick ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 11520904
• MDR Text Key: 243185252
• Report Number: 3017425145-2021-00006
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Device Lot Number: 1037501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 74